EXPAREL vs Lidocaine for Pleural Cancer

Overseen By Horiana Grosu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergies, Pregnancy, Advanced liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether EXPAREL or lidocaine provides more comfort during certain medical procedures for pleural cancer. It targets individuals requiring a pleuroscopy with biopsies and a pleural catheter (a tube placed in the chest). The trial divides participants into two groups: one receives lidocaine, and the other receives liposomal bupivacaine, a version of bupivacaine used for pain relief. Candidates include those with pleural cancer needing these procedures, provided they have no allergies to the medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that liposomal bupivacaine, also known as EXPAREL, is generally safe and well-tolerated for managing pain. Studies have found that a single injection of EXPAREL usually does not cause serious side effects for most people. However, some side effects have been reported, so discussing any concerns with a doctor is important.

Lidocaine, a well-known local anesthetic, is often used in medical procedures. It is generally considered safe when used correctly, and most people tolerate it well. However, like any medication, it can cause side effects in some cases.

For those considering joining a clinical trial with these treatments, discussing all potential risks and benefits with a healthcare provider is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pleural cancer?

Researchers are excited about liposomal bupivacaine because, unlike standard treatments like lidocaine, it offers prolonged pain relief by releasing the anesthetic slowly over time. This slow release targets the intercostal nerve block, potentially reducing the need for frequent dosing and enhancing patient comfort. Lidocaine, on the other hand, is a well-established anesthetic used for immediate pain relief at incision sites, offering a known and trusted option for managing pain during pleuroscopy. Both treatments offer unique benefits that could improve pain management in pleural cancer patients.

What evidence suggests that this trial's treatments could be effective for pleural cancer?

This trial will compare liposomal bupivacaine and lidocaine for pain management after pleural procedures. Research has shown that liposomal bupivacaine might be effective for managing pain after medical procedures. Some studies suggest it could lower certain tumor markers, potentially leading to better long-term outcomes. However, when compared directly to regular bupivacaine, some studies found no difference in the need for additional pain medication. In contrast, lidocaine is a common local anesthetic known for providing quick pain relief during medical procedures. It effectively numbs small areas, helping patients feel more comfortable immediately. Participants in this trial will receive either liposomal bupivacaine or lidocaine to determine which offers better pain relief after pleural procedures. ^{2 3 6 7 8}

Who Is on the Research Team?

Horiana Grosu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 referred for pleuroscopy with biopsies and chest procedures, who can consent to treatment. It's not suitable for those allergic to EXPAREL or lidocaine, pregnant individuals, patients needing pleurodesis, or those with advanced liver disease.

Inclusion Criteria

I am older than 18 years.

I am referred for a lung procedure to collect tissue samples and manage fluid.

Exclusion Criteria

I need a procedure to close the space between my lung and chest wall.

My doctor thinks a procedure is too risky due to my advanced liver disease.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either liposomal bupivacaine or lidocaine as a local anesthetic during pleuroscopy with pleural biopsy and indwelling pleural catheter placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedural chest pain and narcotic use at discharge, 24 hours, and 48 hours post-procedure

2 days

2 visits (virtual or phone)

Long-term follow-up

Participants are monitored for global chest pain score through study completion

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine
• Liposomal Bupivacaine

Trial Overview The study compares the effectiveness of two local anesthetics—EXPAREL and lidocaine—in providing comfort during pleuroscopy with biopsy and catheter placement in patients with pleural tumors or mesothelioma.

How Is the Trial Designed?

Group I: Group A (liposomal bupivacaine) Experimental Treatment 2 Interventions

Patients receive liposomal bupivacaine via injection into the intercostal nerve block.

Group II: Group B (lidocaine) Active Control 2 Interventions

Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).

The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. Jacobus, D., Mehr, S., Ziccardi, V.[2021]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

In a study involving 100 patients with pulpal necrosis, liposomal bupivacaine did not show a statistically significant improvement in postoperative pain relief compared to standard bupivacaine, with success rates of 29% and 22% respectively.

While liposomal bupivacaine had some effects on soft tissue numbness and non-narcotic medication use, these effects were not clinically significant, indicating that it may not provide additional benefits over traditional bupivacaine for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. Glenn, B., Drum, M., Reader, A., et al.[2017]

Liposomal bupivacaine (LB) is safe for use in pediatric patients and significantly improves pain control after pharyngoplasty, as evidenced by lower pain scores compared to those receiving standard lidocaine.

Patients treated with LB had earlier oral intake, required fewer opioids, and were discharged from the hospital nearly 2 days earlier than those in the control group, highlighting its efficacy in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. Day, KM., Nair, NM., Griner, D., et al.[2018]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12432565/

Effects of liposomal bupivacaine for erector spinae plane ... At the 3-month follow-up, the liposomal bupivacaine group showed significantly lower levels of tumor markers, particularly sPD-L1 (all P < 0.001). Conclusions: ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961018310055

Comparison of cost and outcomes in patients receiving ... This study compares liposomal bupivacaine (LB) as an alternative method for pain control and compares it to the standard.

3. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(22)00350-2/fulltext

Randomized Trial of Bupivacaine Versus Liposomal ... The results of this randomized controlled trial comparing bupivacaine and LipoB did not find any difference in the total intake of narcotic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496121/

Effect of liposomal bupivacaine combined with ... This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle ...

5. jto.org jto.org/article/S1556-0864(18)32411-0/pdf

P2.15-12 Exparel vs. Bupivicaine for Postoperative ... oncological treatment, and outcomes were extracted from chart review. Factors associated with HUS were identified using ANOVA. Result: 272.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975001/

Real-World Pharmacovigilance Analysis of Adverse Events ... The analysis revealed 8,023 AE reports in total. Liposomal bupivacaine had 58 positive safety signals, 24 of which were off-label and listed in ...

7. fda.gov fda.gov/media/111001/download

EXPAREL Safety Conclusions. 6.7. Results of the clinical program demonstrate that EXPAREL is safe and well tolerated when administered as a single ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/9/e101171.full.pdf

Effect of liposomal bupivacaine This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle ...